ASTM_D_6977_-_04_2010.pdf

Designation:D697704(Reapproved 2010)Standard Specification forPolychloroprene Examination Gloves for MedicalApplication1This standard is issued under the fixed designation D6977;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification provides certain requirements forpolychloroprene rubber gloves used in conducting medicalexaminations and diagnostic and therapeutic procedures.1.2 This specification covers polychloroprene rubber exami-nation gloves that fit either hand,paired gloves,and gloves bysize.It also provides for packaged sterile or non-sterile or bulknon-sterile polychloroprene rubber examination gloves.1.3 This specification is similar to that of D3578 StandardSpecification for Rubber Examination Gloves,and D6319Standard Specification for Nitrile Examination Gloves forMedical Applications.2.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD3578 Specification for Rubber Examination GlovesD3767 Practice for RubberMeasurement of DimensionsD5151 Test Method for Detection of Holes in MedicalGlovesD6124 Test Method for Residual Powder on Medical GlovesD6319 Specification for Nitrile Examination Gloves forMedical ApplicationD6355 Test Method for Human Repeat Insult Patch Testingof Medical Gloves2.2 ISO Standard:ISO 2859 Sampling Procedures and Tables for Inspection byAttributes32.3 Other Document:U.S.Pharmacopeia43.Significance and Use3.1 This specification is intended as a referee procedure forevaluating the performance and safety of polychloroprenerubber examination gloves.It is not intended for testing prior toroutine lot release.The safe and proper use of polychloroprenerubber examination gloves is beyond the scope of this speci-fication.4.Material4.1 Any polychloroprene rubber compound that producesexamination gloves that meet the requirements of this specifi-cation are allowed.4.2 A lubricant that meets the current requirements of theU.S.Pharmacopoeia for absorbable dusting powder may beapplied to the glove.Other lubricants may be used if theirsafety and efficacy have been previously established.4.3 The inside and outside surface of the polychloroprenerubber examination gloves shall be free of talc.5.Performance Requirements5.1 Gloves,sampled in accordance with Section 6,shallmeet the following referee performance requirements:5.1.1 Products comply with requirements for sterility whentested in accordance with 7.2 when labeled sterile,5.1.2 Shall comply with freedom from holes when tested inaccordance with 7.3,5.1.3 Have consistent physical dimensions in accordancewith 7.4,5.1.4 Have acceptable physical property characteristics inaccordance with 7.5,5.1.5 Have a powder residue limit in accordance with 7.6,and1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved May 1,2010.Published September 2010.Originallyapproved in 2004.Last previous edition approved in 2004 as D6977 041.DOI:10.1520/D6977-04R10.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.4U.S.Pharmacopeia,latest edition,Mack Publishing Co.,Easton,PA 19175.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.1.6 Have a recommended maximum powder limit inaccordance with 7.7.6.Sampling6.1 For referee purposes,gloves shall be sampled fromfinished product,after sterilization when labeled sterile,andinspected in accordance with ISO 2859.The inspection levelsand acceptable quality levels(AQL)shall conform to thosespecified in Table 1,or as agreed upon between the purchaserand the seller,if the latter is more comprehensive.7.Referee Test Methods7.1 The following tests shall be conducted to ensure therequirements of Section 8,as prescribed in Table 1.7.2 Sterility TestTesting for sterility shall be conducted inaccordance with the latest edition of the U.S.Pharmacopeia.7.3 Freedom from HolesTesting for freedom from holesshall be conducted in accordance with Test Method D5151.7.4 Physical Dimensions Test:7.4.1 The gloves shall comply with the dimension require-ments prescribed in Table 2.7.4.2 The length shall be expressed in millimeters as mea-sured from the outside tip of the middle finger to the outsideedge of the cuff.7.4.3 The width of the palm shall be expressed in millime-ters as measured at a level